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Bruton's Tyrosine Kinase (BTK) Inhibitor

Acalabrutinib for Waldenström Macroglobulinemia

Phase 2

Waitlist Available

Research Sponsored by Acerta Pharma BV

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Previously treated cohort only: A confirmed diagnosis of WM, which has relapsed after, or been refractory to ≥1prior therapy for WM and which requires treatment

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 3.8 years. data cut at last subject have completed cycle 27 (28 days per cycle).

Awards & highlights

Study Summary

This trial will test a new drug, acalabrutinib, to see if it is safe and effective in treating people with Waldenström macroglobulinemia.

Who is the study for?

This trial is for adults with Waldenström Macroglobulinemia (WM), a type of blood cancer. It's open to those who haven't been treated before and want an alternative to chemoimmunotherapy, as well as patients whose WM has returned or didn't respond to at least one prior treatment. Participants must be able to swallow capsules and agree to use effective contraception if applicable.Check my eligibility

What is being tested?

The study is testing Acalabrutinib (ACP-196) for safety and effectiveness in treating WM. Researchers will look at how the body processes the drug, its impact on the disease, and any potential benefits it may offer.See study design

What are the potential side effects?

While not explicitly listed here, side effects could include typical reactions seen with cancer treatments such as nausea, fatigue, bleeding issues due to blood thinners being prohibited during the trial, possible liver function changes indicated by eligibility criteria related to organ functions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My Waldenstrom macroglobulinemia (WM) has returned or didn't respond to treatment and needs more treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 3.8 years. data cut at last subject have completed cycle 27 (28 days per cycle).

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 3.8 years. data cut at last subject have completed cycle 27 (28 days per cycle).

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 3.8 years. data cut at last subject have completed cycle 27 (28 days per cycle). for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Overall Response Rate (ORR) of Acalabrutinib in Subjects as Assessed by Investigator Per IWWM 3rd Criteria

Overall Response Rate (ORR) of Acalabrutinib in Subjects as Assessed by Investigator Per IWWM 6th Criteria

Secondary outcome measures

Overall Survival (OS) of Acalabrutinib by Investigator

Progression-free Survival (PFS) of Acalabrutinib by Investigator

Summary of Duration of Response (DOR)

Trial Design

2Treatment groups

Experimental Treatment

Group I: Treatment NaïveExperimental Treatment1 Intervention

Subjects with treatment-naïve Waldenström Macroglobulinemia. N=14

Group II: Previously TreatedExperimental Treatment1 Intervention

Subjects previously treated with Waldenström Macroglobulinemia N=92

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Acerta Pharma BVLead Sponsor

45 Previous Clinical Trials

5,818 Total Patients Enrolled

AstraZeneca Clinical study Information CenterStudy Director1-877-240-9479 information.center@astrazeneca.com

Media Library

Acalabrutinib (ACP-196) (Bruton's Tyrosine Kinase (BTK) Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02180724 — Phase 2

Waldenström's Macroglobulinemia Research Study Groups: Previously Treated, Treatment Naïve

Waldenström's Macroglobulinemia Clinical Trial 2023: Acalabrutinib (ACP-196) Highlights & Side Effects. Trial Name: NCT02180724 — Phase 2

Acalabrutinib (ACP-196) (Bruton's Tyrosine Kinase (BTK) Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02180724 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any other research studies that have looked at Acalabrutinib (ACP-196)?

"Acalabrutinib (ACP-196) is being studied in 76 clinical trials, 11 of which are Phase 3 studies. Most of these Acalabrutinib (ACP-196) trials are based out of Houston, Texas; though, there are 2,423 locations conducting clinical trials for Acalabrutinib (ACP-196)."

Answered by AI

What is the age limit for patients who can participate in this clinical trial?

"The age limit for patients enrolling in this study is 18-130 years old."

Answered by AI

Who would be a likely candidate to sign up for this kind of research?

"The eligibility criteria for this study includes a diagnosis of waldenstrom macroglobulinemia and being between 18-130 years old. A total of 106 individuals will be enrolled in the trial."

Answered by AI

At how many locations is this trial currently taking place?

"There are 11 enrolment sites for this study which are situated in Santa Barbara, Washington, New york and 8 other locations. If you want to limit travel, it might be best to choose a location near you."

Answered by AI

What is the primary purpose of Acalabrutinib (ACP-196)?

"Acalabrutinib (ACP-196) has been shown to be an effective treatment for mantle cell lymphoma (mcl), small lymphocytic lymphoma, and chronic lymphocytic leukemia (cll)."

Answered by AI

Are researchers still enrolling new participants for this trial?

"The clinicaltrials.gov website reveals that this study is not currently looking for patients to enroll. The trial was initially posted on September 8th, 2014 and received its last update on March 17th, 2022. There are a total of 165 other trials recruiting participants at this time."

Answered by AI

When can patients in the United States expect to have access to Acalabrutinib (ACP-196)?

"There is preclinical evidence suggesting that Acalabrutinib (ACP-196) is safe, but efficacy has not been tested yet. Therefore, it received a score of 2."

Answered by AI

What is the innovative aspect of this clinical trial?

"Acalabrutinib (ACP-196) is being studied in 76 active clinical trials across 47 countries and 504 cities. The first trial for Acalabrutinib was sponsored by Acerta Pharma BV and completed its Phase 1 & 2 drug approval stage in 2014 with 306 patients. In the 6 years since then, 24 more trials have been conducted."

Answered by AI

How many people are eligible to participate in this research project?

"As of now, this particular clinical trial is not looking for new patients. According to the information available, the first posting was on September 8th, 2014 and the most recent edit was done on March 17th, 2022. 89 other trials are currently recruiting patients who have waldenstrom macroglobulinemia and there are 76 ongoing studies involving Acalabrutinib (ACP-196)."

Answered by AI

Recent research and studies

The Lancet HaematologyJournal

Acalabrutinib Monotherapy in Patients with Waldenström Macroglobulinemia: A Single-arm, Multicentre, Phase 2 Study

Owen, Roger G, Helen McCarthy, Simon Rule, Shirley D'Sa, Sheeba K Thomas, Olivier Tournilhac, Francesco Forconi, et al.. 2020. “Acalabrutinib Monotherapy in Patients with Waldenström Macroglobulinemia: A Single-arm, Multicentre, Phase 2 Study”. The Lancet Haematology. Elsevier BV. doi:10.1016/s2352-3026(19)30210-8.

clinicaltrials.govStudy

An Open-label, Phase 2 Study of ACP-196 in Subjects With Waldenström Macroglobulinemia

2014. "An Open-label, Phase 2 Study of ACP-196 in Subjects With Waldenström Macroglobulinemia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02180724.

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